Develop, review, and submit regulatory applications (e.g., IRB. FDA submissions) for clinical research.
Assist with interpretation and application of regulations (FDA, EMA, ICH, GCP, local regulations) to clinical research programs.
Maintain up-to-date knowledge of applicable regulatory requirements and communicate changes to relevant stakeholders.
Liaise with regulatory agencies and ethics committees; manage correspondence and responses.
Support clinical research teams in preparing regulatory aspects of IRB applications, amendments, and informed consent documents.
Oversee maintenance of regulatory files and ensure accurate record-keeping for compliance audits/inspections.
Provide regulatory guidance during study start-up, conduct, and close-out.
Review and advise on sponsor-investigator initiated research to ensure regulatory compliance.
Train internal research staff on regulatory requirements and processes.
Participate in internal/external audits and inspections; address regulatory findings.
Coordinates department or clinic compliance with a moderate level of guidance.
Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
Performs other related work as needed.
Requirements
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
Certifications:
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Preferred Competencies
Experience interacting with local and central IRBs and other regulatory bodies.
Familiarity with electronic regulatory submission platforms.
Certification in Regulatory Affairs (e.g., RAPS, CRA) is a plus.
Working Conditions
Office environment.
Application Documents
Resume (required)
Cover Letter (preferred)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Legal & Regulatory Affairs
Role Impact
Individual Contributor
Scheduled Weekly Hours
40
Drug Test Required
No
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
Salary
FLSA Status
Exempt
Pay Range
$65,000.00 - $90,000.00 The included pay rate or range represents the University's good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
Yes The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook .
Posting Statement
Benefits
Health insuranceVision insurance
Additional Information
Department
BSD OCR - Clinical Research Operations
About the Department
The Office of Clinical Research (OCR) is the nucleus of the clinical research enterprise, providing services, training, tools and compliance oversight to support the conduct of clinical research across the entire Biological Sciences Division and University of Chicago Medicine human subject research portfolio.
The mission of the Office of Clinical Research is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers. Together, we elevate the human experience with knowledge and health care.
Job Summary
The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation.
The Regulatory Affairs Manager is part of the Research Incubation Unit of the Office of Clinical Research. The Clinical Research Incubation Unit was established to enable growth of clinical research portfolios across the Biological Sciences Division as well as provide timely research staffing services to departments or units in need of short-term clinical research management services.
The Regulatory Affairs Manager is responsible for ensuring that clinical research activities comply with relevant regulatory requirements, guidelines, and standards. This role manages regulatory submissions, oversees compliance documentation, coordinates interactions with regulatory authorities, and provides guidance to research teams on regulatory issues, contributing to safe and ethical conduct of clinical trials.
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